Ayurvedic Herbs and Herbal Formula Manufacturing

 1.8 Ayurvedic Herbs and Herbal Formula Manufacturing 

Ayurvedic medicines are marketed in various forms. They are available in the classical forms like gutikas (tablets), churnas (powder), asavas and aristas (fermented products), ghritas (medicated ghee), and kashayams (decoctions). For topical use, drops, creams, lotions, liniments, and ointments are available. Dried plant extracts in capsule form are also in use. In addition, many patent drugs are sold in other modern drug presentation forms like syrups, granules, creams, lotions, etc., which constitute around 65% of the market share. There are more than 8500 manufacturers of Ayurvedic drugs in the country, of which the annual return of 10 firms is more than Rs. 50 crores (approximately US $5 million — $1.00 is roughly equal to Rs. 48 crores), of 25 firms is between Rs. 5 and 50 crores, of 965 firms is between Rs. 1 and 5 crores, and the remaining is very small with an annual turnover of less than Rs. 1 crore. The market share of Ayurvedic drugs is around Rs. 3500 crores and that of Siddha drugs is around Rs. 5 crores.3 

Ayurveda is covered by the Drugs and Cosmetic Act (1940) and Rules (1945) of the country, and the manufacturer is expected to comply with the rules delineated under this act. In 1960, Chapter IV and other related chapters were added. Chapter IV deals with the manufacture, sale, and distribution of drugs and cosmetics; Chapter IV-A, which was subsequently added, deals with provisions related to Ayurvedic, Siddha, and Unani drugs. In this chapter, 19 sections dealing with different aspects have been described. All the drug manufacturing and dispensing activity in the country is covered under this act. According to Clause 3(a) of this act, the definition of Ayurvedic drugs includes all medicines intended for internal and external use for or in the diagnosis, treatment, mitigation, or prevention of disease or disorder in human beings or animals and manufactured exclusively in accordance with the formulae prescribed in the author- itative texts of Ayurveda (which have been specified in the First Schedule of the act). Clause 3(h) describes patent and proprietary medicines. This refers to formulations prepared utilizing the drugs listed in the formulae mentioned in the authoritative texts and mentioned under Schedule I but excludes drugs administered by parenteral route and formulations mentioned in the books in the First Schedule.7 Schedule E1 of the act contains a list of poisonous substances under the Ayurvedic and Unani system. In addition to the above, other acts that are relevant to the manufacturing of Ayurvedic drugs are the (1) Medicine and Toiletry Preparation Act, (2) Magic Remedies and Objectionable Advertisement Act, (3) Poisons Act, (4) Weights and Measurement Act, (5) Shops and Establishment Act, (6) Dangerous Drugs (Psychotropic and Narcotic Substances) Act, (7) Patents Act, and, in the future, the (8) Biodiversity Act (which is in the offing). 

Three types of agencies are involved in the administration of the acts and rules mentioned above: the Drug Technical Advisory Board and Drug Consultative Committee, which act as advisory bodies;8 drug testing laboratories, which provide support by shouldering the analytical responsibilities; and licensing and controlling authorities, which function as the executive wing. The Technical Advisory Board and the Drug Consultative Committee have been set up to advise the government on matters relating to ISM drugs. The Drug Technical Advisory Board (Ayurveda, Siddha, and Unani Technical Advisory Board) has been functioning regularly. The Drug Controller General of India is in charge of licensing and enforcing the above acts and rules. At the state level are drug controllers or Food and Drug Administration Commissioners who shoulder this responsibility. The drugs manufactured in the Ayurvedic sector are also under their controlling authority. In some states, like Kerala, there are officers trained in Ayurveda who provide technical assistance to the enforcing authorities. 

Manufacturing of Ayurvedic drugs, except in accordance with the prescribed standards, is prohibited. It is essential to obtain a license from the licensing authority to manufacture Ayurvedic drugs. Separate licensing is required for each of the manufacturing premises maintained by the manufacturer. Manufacturing activity can also be undertaken through a loan license. For drug manufacturing, it is necessary to maintain a certain level of hygiene and optimum manufacturing conditions. These conditions are specified in Schedule T of the act (mentioned under the schedule to the rules). On 23rd June 2000 an amendment was made in the above act to specify GMP for Ayurveda, Siddha, and Unani drugs. Notice was made to ensure that (1) raw materials used in the manufacture of drugs are authentic, of prescribed quality, and are free from contamination; (2) drugs are manufactured according to standard conditions; (3) adequate quality control measures are adopted; and (4) the manufactured preparations released to the marketplace are of acceptable quality The ISM drug-manufacturing industry is in the process of technical upgrading to comply with GMP norms prescribed by the government of India. To achieve the objectives listed above, each licensee is expected to evolve methodology and procedures for following the prescribed process of manufacture of drugs, which should be documented as a manual and kept for reference and inspection. However, teaching institutions and registered, qualified Vaidyas, Siddhas, and Hakeems who prepare medicines on their own to dispense to their patients and not to sell such drugs in the market are exempt from the purview of this practice. Part I of two parts contains specification regarding the maintenance of factory premises; Part II contains the list of machinery, equipment, and minimum manufacturing premises required. 

For the implementation of drug testing provisions under the Drugs and Cosmetics Act (1940) and Rules (1945), it is necessary to evolve pharmacopoeial standards. At present, pharmacopoeial standards are available for 258 drugs, and 654 formulations have been published in the Ayurvedic Formulary of India. The Department of ISM is developing pharmacopoeial standards through pharmacopoeial committees. Three volumes of Part I of the pharmacopoeia, called Ayurvedic Pharmacopoeia, have been published containing 258 monographs. The target is to cover 600 single drugs. 

At present, there are more than 8000 licensed pharmacies in the country manufacturing Ayurvedic drugs. There is the Mumbai-based Ayurvedic Drug Manufacturer’s Association which can be contacted for further details about issues related to Ayurvedic drug manufacturing. 

A drug-control cell in the Department of ISM deals with various issues pertaining to quality control, import, export, classification of drugs under the Drugs and Cosmetics Act, patents, and the establishment of a TKDL. It monitors and coordinates implementation of legislation relating to drugs of ISM & H. The agency may be a good source for information on matters related to regulations. 

Soure: Lakshmi chandra Mishra, scientific Basis for Ayurvedic Therapies; 2004 by CRC Press LLC